Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Mobius PT-INR Accuracy Clinical Study|
- PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device [ Time Frame: Five days to collect data and up to two weeks to generate correlation graph ] [ Designated as safety issue: No ]To determine the correlation of PT/INR values between an experimental and commercial device
|Study Start Date:||September 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Subjects currently receiving coumadin (warfarin) treatment.
|United States, Arkansas|
|White River Diagnostic Clinic|
|Batesville, Arkansas, United States, 72501|
|Principal Investigator:||Richard Ward, Pharm.D||Harding University|